Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00662194|
Recruitment Status : Unknown
Verified March 2014 by Bayside Health.
Recruitment status was: Recruiting
First Posted : April 21, 2008
Last Update Posted : March 10, 2014
|Condition or disease|
|HIV-hepatitis Co-infection HIV Infections|
It has been demonstrated that Toll-like receptors (TLR) are involved in viral hepatitis - hepatitis B (HBV), hepatitis C (HCV) - and HIV in the setting of mono-infection. However the role of innate immunity in the pathogenesis of HIV-hepatitis co-infection in both natural and therapy-associated viral clearance remains unclear. The data from this study may reveal patterns which could predict how and when patients spontaneously, and with therapy, resolve HBV or HCV in the setting of co-infection.
The aim of the study is to evaluate the activity of innate immunity in different subsets of HIV-infected populations co-infected with chronic hepatitis B and/or C. Our hypothesis is that innate immunity is altered in HIV and hepatitis co-infection and that this differs from both hepatitis and HIV mono-infection.
The study is a cross-sectional and longitudinal pilot study of individuals infected with HIV and either HBV or HCV.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||October 2014|
HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3
HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3
HIV-HBV co-infected and receiving ART and CD4 count <200cells/mm3
HIV-HBV co-infected and not receiving ART
HIV-HCV co-infected & receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3
HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3
HIV-HCV co-infected and receiving ART and CD4 count <200cells/mm3
HIV-HCV co-infected and not receiving ART
- TLR change with HIV co-infection therapy [ Time Frame: 6 months ]
- TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting [ Time Frame: 6 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662194
|Contact: Jennifer Audsley, PhD||+613 firstname.lastname@example.org|
|The Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jennifer Audsley, PhD +613 99030184 email@example.com|
|Sub-Investigator: David Iser, MD|
|Principal Investigator: Joe Sasadeusz, MD, PhD|
|Principal Investigator:||Joe Sasadeusz, MD, PhD||The Alfred|